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Health informatics - Data exchange standards - HL7 clinical document architecture(release 2)
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GB/T 42384-2023
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Basic data | Standard ID | GB/T 42384-2023 (GB/T42384-2023) | | Description (Translated English) | Health informatics - Data exchange standards - HL7 clinical document architecture(release 2) | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C07 | | Classification of International Standard | 35.240.80 | | Word Count Estimation | 264,264 | | Date of Issue | 2023-03-17 | | Date of Implementation | 2023-03-17 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 42384-2023: Health informatics - Data exchange standards - HL7 clinical document architecture(release 2)
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS35:240:80
CCSC07
National Standards of People's Republic of China
Health Informatics Data Exchange Standard
HL7 Clinical Document Schema (version 2)
Released on 2023-03-17
2023-03-17 Implementation
State Administration for Market Regulation
Released by the National Standardization Management Committee
table of contents
Preface I
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Abbreviations 2
5 CDA Overview 3
5:1 What is CDA 3
5:2 General concept of CDA 4
5:3 CDA compliance 7
5:4 Scalability of CDA 8
5:5 Forward and backward compatibility 9
6 Introduction to CDA Technology Artifacts 10
6:1 Overview 10
6:2 HL7 Reference Information Model 10
6:3 HL7V3 data type 10
6:4 HL7 vocabulary domain 10
6:5 HL7CDAR-MIM 11
6:6 HL7CDA level description 11
6:7 XML implementation of HL7CDA 11
7 CDA document exchange in HL7 messages 11
8 CDAR-MIM 15
8:1 Overview 15
8:2 Clinical documentation 18
8:3 Document header 18
8:4 Document body 37
8:5 CDA context 65
9 CDA level description 67
10 XML Implementation of CDA 68
Appendix A (Informative) CDA Narrative Block Pattern Example 69
Appendix B (informative) Datatypes:xsd file example 82
Appendix C (informative) Datatypes-base:xsd file example 115
Appendix D (informative) POCD_MT000040:xsd file example 159
Appendix E (informative) voc:xsd file example 206
References 259
foreword
This document is in accordance with the provisions of GB/T 1:1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules for Standardization Documents"
drafting:
This document is modified to adopt ISO /HL727932:2009 "Data Exchange Standard HL7 Clinical Document Architecture, Version 2":
Compared with ISO /HL727932:2009, this document has made the following structural adjustments:
---Adjust 3:8 and 3:9 of ISO /HL727932:2009 to 3:7 and 3:8 of this document;
--- Deleted the title of Chapter 5 of ISO /HL727932:2009 "5 HL7 Clinical Document Architecture (Version 2)";
---Adjust 5:1~5:6 of ISO /HL727932:2009 to Chapter 5~Chapter 10 of this document;
--- Added 5:1:1, 5:3:1, 6:1, 8:1, 8:3:1, 8:3:2:1, 8:3:3:1, 8:3:4:1, 8:4:1:1, 8:4:2:1, 8:4:5:1, 8:4:6:1,
Section number and title of 8:4:7:1;
--- Deleted 6:1, 6:2 and Appendix A to Appendix G of ISO /HL727932:2009;
--- Added Appendix A ~ Appendix E;
--- Added references:
The technical differences between this document and ISO /HL727932:2009 and their reasons are as follows:
---Modified the scope of Chapter 1 (see Chapter 1, Chapter 1 of ISO /HL727932:2009) to adapt to my country's national conditions;
---Added normative references to "HL7 Glossary" (see 6:4), "HL7V3XML Implementable Technical Specification" (see 5:2:4), "HL7
V3 Standard: Data Type Abstract Specification (Version 1)" (see 6:3), "XML Implementable Technical Specification Data Type" (see
6:3), IETFRFC2046 (see Chapter 7), IETFRFC2557 (see Chapter 7), IEFTRFC3066 (see 8:3:2:7,
8:4:2:7), to adapt to my country's national conditions;
--- Deleted 3:7 of ISO /HL727932:2009, because it is not used in the text;
--- Deleted the abbreviations EU, HMD, ICH, ISO , ITS, SDO (see Chapter 4 of ISO /HL727932:2009), because they are in
unused in the text;
--- Increased abbreviations CE, CNE, CWE, DICOM, DTD, ED, LOINC (see Chapter 4) to adapt to my country's national conditions;
--- Deleted 5:1:1:2 of ISO /HL727932:2009 (see 5:1:1:2 of ISO /HL727932:2009), because it is inconsistent with Chapter 1
The contents of "scope" are duplicated exactly:
The following editorial changes have been made to this document:
---Modify the name of the standard to "Health Informatics Data Exchange Standard HL7 Clinical Document Architecture (Version 2)";
--- Change "[ENV1613:1995][ISO 21574-7]" in 3:3 to "[Source: ENV1613:1995,3:13;
ISO 21549-7:2016, 3:9]" (see 3:3, 3:3 of ISO /HL727932:2009);
---Unify the "R-MIM" and "RMIM" of ISO /HL727932:2009 into "R-MIM";
--- Deleted the explanatory content such as the informative description of ISO /HL727932:2009 (see 5:1:1:2 of ISO /HL727932:2009,
5:1:2:1, 5:1:2:2, 5:1:4, 5:2:6, 5:A, 5:B, 8:3:2:3)
--- Deleted Appendix A to Appendix G of ISO /HL727932:2009;
--- Added Appendix A (informative) "CDA narrative block pattern example";
--- Added Appendix B (informative) "Datatypes:xsd file example";
--- Added Appendix C (informative) "Datatypes-base:xsd file example";
--- Added Appendix D (informative) "POCD_MT000040:xsd file example";
--- Added Appendix E (informative) "voc:xsd file example";
--- Added references:
Please note that some contents of this document may refer to patents: The issuing agency of this document assumes no responsibility for identifying patents:
This document is proposed and managed by China National Institute of Standardization:
This document was drafted by: China National Institute of Standardization, General Hospital of the Chinese People's Liberation Army, Beijing University of Aeronautics and Astronautics, Fujian Province Zhongke Standard
Technology Co:, Ltd:, Zhuhai Dingji Standard Technology Co:, Ltd:, Zhejiang Fengan Biopharmaceutical Co:, Ltd:, Shenzhen Huada Life Science Research
Hospital, Zhejiang Institute of Digital Medical and Health Technology, Linqing People's Hospital, Huzhou First People's Hospital, Zhijiang Laboratory, Xi'an Boda Software
Co:, Ltd:, Shanghai University of Traditional Chinese Medicine, National Health Commission Science and Technology Research Institute, Chinese Academy of Chinese Medical Sciences Institute of Traditional Chinese Medicine Information,
China Technology Entrepreneurship Association, Shenzhen Health Development Research and Data Management Center, China Jiliang University, Hebei Xiongan Haichen Technology Development
Co:, Ltd:, Beijing Tiantan Hospital Affiliated to Capital Medical University, Shenzhen Tongbiao Technology Co:, Ltd:, Sichuan Jiubacun Information Technology Co:, Ltd:,
Hunan Yilingtang Medical Technology Co:, Ltd:, Xuanlange (Beijing) Health Consulting Co:, Ltd:, Xianxian Hospital of Traditional Chinese Medicine, Management Department of Anhui Yilian Hospital
Technology Co:, Ltd:, Shanghai Pudong New Area Traditional Chinese Medicine Hospital, Shantou Xindejia Biotechnology Co:, Ltd:, Chaozhou Hede Biotechnology Co:, Ltd:,
Liaocheng People's Hospital:
The main drafters of this document: Tang Peifu, Ren Guanhua, Zhang Jicong, Pei Fei, Chen Xiaohong, Qiao Baoliang, Li Gen, Ding Xiaoxiao, Wang Ran, Cha Yuzhong,
Li Yingying, Feng Wenming, Song Fang, Li Jinsong, Zhou Tianshu, Wang Yijie, Li Jing, Ma Xu, Wang Yuanyuan, Li Haiyan, Fan Yihui, Wu Peikai, Fu Huilan,
Wang Guiying, Li Xue, Zhang Hao, Zhang Licheng, Liu Wanhang, Li Jiantao, Wang Daofeng, Zhang Qian, Yin Zihan, Yao Keqin, Li Jinxuan, Wang Peng, Rao Hongshun,
Liu Jingkai, Ran Xi, Jie Min, Hu Zongde, Xu Li, Tang Xiudan, Bai Yudi, Zeng Huatang, Qiu Liya, Zhao Xingwei:
Health Informatics Data Exchange Standard
HL7 Clinical Document Schema (version 2)
1 Scope
This document defines the relevant terms and definitions of Clinical Document Architecture (CDA), describes the technical artifacts of CDA, and specifies the HL7 consumer
According to the requirements of exchanging CDA documents in information, CDAR-MIN, CDA level description and XML implementation of CDA are given:
The following are outside the scope of this document:
---Exchange clinical document data format outside the context (such as the data format used to store clinical documents);
--- HL7 messages specially designed for clinical document transmission;
--- Document creation and management:
This document is applicable to the development and management of clinical documents for data exchange in healthcare information systems:
2 Normative references
The contents of the following documents constitute the essential provisions of this document through normative references in the text: Among them, dated references
For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to
this document:
GB/T 30107-2013 Health Informatics HL7V3 Reference Information Model (ISO /HL721731:2006, MOD)
Note: There is no technical difference between the referenced content of GB/T 30107-2013 and the referenced content of ISO /HL721731:2006:
HL7 vocabulary (HL7Vocabulary)
Specification, Release1)
3 Terms and Definitions
The following terms and definitions apply to this document:
3:1
A document markup standard that specifies the structure and semantics of clinical documents intended for exchange:
3:2
Contains or points to an XML document type declaration that provides the syntax for a certain type of document:
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